Peridialysis Project: The Influence of Predialysis Factors on the Initial Course of Dialysis
试验速览
- 阶段
- 不适用
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Proportion of patients who start planned dialysis initiation as defined by the protocol
研究概览
简要总结
The present study plans to delineate the clinical, biochemical, sociological and psychological factors. involved in dialysis preparation, and their impact on dialysis initiation (DI), modality choice and prognosis. In particular the following questions are to be answered.
- What factors influence unplanned DI?
- What factors influence choice of dialysis modality?
- What factors influence choice of dialysis access?
- Why do physicians start dialysis?
- What factors in the predialytic period and its immediate aftermath (the "peridialytic" period) influence prognosis?
详细描述
Patients All patients starting active end stage renal disease (ESRD) treatment at the participating centres and their satellite centres.
No. Patients: 1000.
- Patients who have received their recent predialysis care at another centre can be included if the previous centre's notes are available, otherwise not.
- Patients receiving a preemptive transplant are included, even if the transplant is performed at another centre. A patient questionnaire is not required for these patients.
- Africans are excluded (inaccurate estimated glomerular filtration rate (eGFR) calculation) Each patient is allocated a local identity number (1,2,3....). The local author keeps a registry of the true patient identity of each identity number for follow-up purposes. This registry is not to be used in any communication outside the centre.
Comment: Most patients have known chronic uremia at dialysis start. In a few cases, it is unknown whether the uremia is acute or chronic. There are two main groups:
- Acute uremia of unknown origin. Doctors should fill the questionnaire in Table 2, which can be discarded if the patient recovers renal function within three months.
- Acute kidney injury (AKI). Most of these patients will recover within three months, so the questionnaire can wait, and be filled in retrospectively for the few remaining patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 95 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients starting maintenance dialysis therapies at the participating centers
排除标准
- 未提供
结局指标
主要结局
Proportion of patients who start planned dialysis initiation as defined by the protocol
时间窗: 1 year
Planned dialysis The patient's first dialysis is planned if: 1. His first hemodialysis uses an AV fistula 2. His first hemodialysis uses a permanent catheter as the patient's permanent access 3. His first peritoneal dialysis is \>6 days after catheter placement. The patient's first dialysis is unplanned if: 1. His first hemodialysis uses a temporary catheter 2. His first hemodialysis uses a permanent catheter as the patient's temporary access (i.e. a later AV fistula is planned. 3. His first peritoneal dialysis is \<7 days after catheter placement.
次要结局
- Choice of dialysis access(1 year)
- Death(1 year)
- Choice of dialysis modality(1 year)